A NEW MALPRACTICE ISSUE FOR HOSPITALS?
Columbia University researchers found being in a bed previously used by a patient with an infection ups your own risk of infection by 583% (SEE ABSTRACT, HERE: https://www.ncbi.nlm.nih.gov/pubmed/29486805), according to the current issue of Infection Control and Hospital Epidemiology. The researchers conclude that “enhanced cleaning measures” are needed.

No kidding. Adequate cleaning is more vital now than ever, because germs are getting deadlier. On April 3, the Centers for Disease Control and Prevention announced that “nightmare bacteria” — causing infections that cannot be cured with most antibiotics — are spreading throughout U.S. hospitals. Fifty percent of patients who get these infections die.

When checking-in, check to make sure that your bed has been properly cleaned.

Several years ago, this blog started as a way to inform physicians and other health care professionals about relevant health law issues. Recently, a blog reported that this blog is in the top 75 nationwide of all healthcare law blogs.

How should physicians deal with contractually arranged pregnancies?
Physicians, particularly obstetricians, dealing with surrogate pregnancies have unique legal and practical issues to face when dealing with the contractual obligations of the surrogate mother.

Physicians are not lawyers and shouldn’t pretend to help the parties with the surrogate contract issues. However, they can help the parties understand the medical issues such contracts create.

Treat Surrogate Mother and the Fetus

According to the recommendations of a 2008 American Congress of Obstetricians and Gynecologists (ACOG) committee opinion, a medical professional’s obligation is to care from the pregnant woman and the fetus.

“While caring for a surrogate mother it is the professional obligation of the obstetrician to support the well-being of the pregnant woman and her fetus, to support the pregnant woman’s goal for the pregnancy, and to provide appropriate care regardless of the patient’s plan to keep or relinquish the child. The obstetrician must make recommendations that are in the best interests of the pregnant woman and her fetus, regardless of prior agreements between her and the intended parents.”

This contrasts sharply with California law since 1993 when the California Supreme Court approved surrogacy agreements for gestational surrogacy (Johnson v. Calvert). The court ruled that as between the genetic relationship of the woman who donated the egg, and the relationship of the surrogate, “she who intended to procreate the child-that is, she who intended to bring about the birth of a child that she intended to raise as her own-is the natural mother under California law.”

The parties who hired the surrogate should be the parents. By making this ruling, the Court signaled it’s intent to look at the intent of the parties to determine who was the parent.

How does the healthcare system respond to conflicts between the birth mom and the contracting parents? The ACOG Opinion requires the physician to support the goals of the pregnancy of the birth mother. The California Supreme Court (later codified), gives the mantel of parenthood to the parties who hired the surrogate. How does the doctor decide when the parties disagree?

California Case Demonstrates the Issues.

One California case demonstrates some of the issues (CM v. MC.) In the case, a 50-year old male postal worker who lived with his mother wanted a male child. Though a surrogacy agency, he contracted with a 47-year old women to carry his surrogate baby. The intended father and the surrogate mother never met. Through the broker, a 75-page agreement was signed. The agreement provided that the mother would receive $27,000, with a $6,000 bonus in the case of multiple pregnancies, that the woman would become impregnated by implantation of donor eggs fertilized by the postal worker’s sperm, and that the intended father would pay medical bills and insurance for the surrogate during the pregnancy. The agreement further provided that the intended father wanted a male child and that in the event of a multiple pregnancy, the intended father had the right to require “selective reduction” of the pregnancy.

The surrogate mother became impregnated by implantation, resulting in a pregnancy of three males. The surrogate mother either did not read or did not understand the agreement she signed. The agreement allowed the intended father to make a decision about selective reduction if there was a multiple pregnancy. The surrogate mother, however, did not believe in abortion. When the father instructed that she reduce the pregnancy, because he was running out of money and could not handle triplets, the surrogate mother refused. Litigation resulted. The end result was that the triplets were born and the intended father got custody.

Guidelines for Treating Surrogate Mothers

The following is a list of guidelines for caring for surrogate mothers.

First a warning: there is little legal guidance for many of these guidelines and there has been too little discussion about the legal obligations of the physician in these situations.Get a copy of the Surrogacy Contract.

The purpose of obtaining this agreement is not to give legal advice or to make decisions based upon the agreement. Rather, knowledge of the agreement can give the obstetrician important information about the medical choices made by the parties. Some of them include:

a. HIPAA Waiver. Surrogate contracts usually give the intended parents the right to information about the pregnancy. This should be reviewed by compliance professionals. If it’s not sufficient, the practices’ HIPAA waiver should be offered to the surrogate so that the intended parents can receive information and possibly attend in office appointments.

b. Surrogate Mother’s Behavior During the Pregnancy. Standard contracts provide for behavior of the surrogate mother during the pregnancy, including diet, abstention from tobacco, achohol, drugs, etc., the utilization of vitamins, exercise, and frequency of visits to the physician. Agreements may even require treatment of the child before birth, like reading to the child, or music, or birth methods, etc.

c. Decision Points During the Pregnancy. The physician can take note of the obligations of the surrogate to make certain decisions, such as DNA testing, or selective reduction as described in the case above.

Note that there is some risk in obtaining the Surrogacy Contract: By having knowledge of the terms of the agreement, a slighted party may try to sue the physician for a tort called “interference with contract.” This would be an allegation that the physician intentionally attempted to get the surrogate to breach the contract. There is no known case in the country for this cause of action at this time.

Follow The Instructions of the Surrogate Mother.

As the pregnancy unfolds, the ideal situation would be when the surrogate mother and the intended parents visit the physicians’ offices together, and they make joint decisions as the pregnancy proceeds. However, if there should be conflict, or if the physician is faced with a situation where the surrogate mother is not following the surrogacy contract, the physician should follow instructions of the surrogate mother unless and until the surrogate parents obtain a court order. The physician should stay out of any legal dispute.

Inform Intended Parents.

As long as the surrogate mother has allowed the intended parents access to medical information, and as long as such waiver of privacy is not terminated by the surrogate mother, the physician should share information about the pregnancy with the intended parents. If such privacy waiver is revoked, the physician should inform the intended parents of such revocation, and stop sharing information without a court order.

Absentee Intended Parents.

Often, the intended parents are absent until the birth. In such cases, the physician should only follow the surrogates instructions during the pregnancy. After Birth Issues.

Generally, surrogate contracts allow intended parents to go into court and get an order of custody at the time of birth. If such an order exists, the intended parents would usually have the right to make all decisions regarding children born to surrogate parents. Without such order, the surrogate mother’s instructions should be followed.

This article is meant as guidelines in an area of law that has no real guidelines. Suggestions or different experiences are welcomed.

Informing physicians about dealing with surrogacy laws, attorney Kinley has developed a program to help obstetricians and other physicians to respond to concerns of surrogate parents and intended parents involved in surrogate contracts to deliver babies.

Comments Off on Matt Kinley speaks to Obstetricians About Surrogacy Law

This is a two part series for physicians on some of the issues that arise with the medical treatment of surrogate mothers. This first article deals with the surrogacy contract.

California Family Code Section 7962 provides:

“The surrogate, her spouse, or partner is not a parent of, and has no parental rights or duties with respect to, the child or children.”

Adding an additional layer to the twenty-first century notion of the family, several children are born not from their mother, but from a third party surrogate. In California, couples seeking children with some genetic connection may use these contracts to pay a surrogate mother to carry the baby through pregnancy.

What is required for a legal contract? The California Supreme Court, in the 1993 decision of Johnson v. Calvert, held that such arrangements are permissible and that the intended mother — and not the surrogate — should be deemed a child’s mother. As of January 1, 2013, California law (AB1217) added to the Family Code the Uniform Parentage Act, cited as Family Code section 7962, which codified California’s acceptance of such contracts.

Physicians, particularly obstetricians, dealing with surrogacy pregnancies have unique legal and practical issues to face when dealing with the relationships between the intended parents and the gestational mother. These relationships are governed by a contract which is defined by the Uniform Parentage Act. Presenting a valid surrogacy agreement to the court rebuts any presumptions that the surrogate and her spouse are the legal parents of the child or children.

For a surrogacy contract to be valid under the statute, the contract must have the following information:

1. The date the contract was executed;

2. The names of the persons from which the gametes [ova and sperm] originated, unless anonymously donated;

3. The name(s) of the intended parent(s); and

4. A disclosure of how the medical expenses of the surrogate and the pregnancy will be handled, including a review of applicable health insurance coverage and what liabilities, if any, that may fall on the surrogate.

Additional requirements are that the agreement must be entered into before any embryo transfer begins; both the intended parent(s) and the surrogate must be represented by separate, independent counsel before executing the agreement; and the agreement must be signed and notarized.

The statute also establishes that, upon proof of a valid surrogacy agreement, the court will terminate the parental rights of the surrogate and her spouse “without further hearing or evidence, unless the court or a party to the assisted reproduction agreement for gestational carriers has a good faith, reasonable belief” that the agreement or accompanying attorney declarations were not executed in accordance with § 7962. Surrogacy contracts will be deemed “presumptively valid” and cannot be rescinded or revoked without a court order.

The statute places no conditions on who can serve as a surrogate (beyond requiring that she not be genetically related to the fetuses) or who may solicit the services of a gestational carrier. No minimum levels of income, intelligence, age, or ability are required for either the surrogate or the intended parent(s).) The statute does not require that the intended parents shoulder all costs associated with surrogacy, and only states that the financial accommodations necessary for the arrangement are to be detailed in the surrogacy contract.

Note that these principles do not apply to “traditional surrogacy.” In a traditional surrogacy, the woman carrying the child is also the genetic mother – as a general rule, she conceives through artificial insemination with the intended father’s sperm, but using her own egg. The law on traditional surrogacy in California remains very unclear, and it is possible that the “traditional surrogate” will be the legal mother and that one or both of the intended parents will end up having to adopt the child.

This is demonstrated in the case of In re Marriage of Moschetta (1994) 25 Cal.App.4th 1218. In that case, Robert Moschetta and Cynthia Moschetta wanted to have a child. Cynthia was sterile. Elvira Jordan agreed to be inseminated with Robert’s sperm, and to carry the baby to term for them. Pursuant to the agreement, Elvira was to allow Robert sole custody, and was to consent to adoption of the child by Cynthia. However, when the Moschettas broke up during her pregnancy, Elvira decided to keep the baby, although when the couple reconciled she relented and allowed the baby to go home with them. Seven months later, the Moschetta’s broke up for good. Cynthia petitioned the court, arguing that Cynthia was the baby’s legal mother, not Elvira, based on the terms of the surrogacy contract and the fact that the baby had lived with Cynthia for most of its short life. In this case, the court held the Johnson v. Calvert did not apply, since Elvira was both the genetic and the gestational mother. Enforcing a prebirth contract to give up one’s baby would go against the public policies relating to parentage and adoption. Legally, Elvira was the mother and Robert was the father.

Finally, additional to as what is required, the agreement should deal with issues such as an agreement as to how the gestational mother will care for herself during the pregnancy, issues related to how the a pregnancy with multiple embryos will be dealt with, genetic testing and consequences as to deal with negative genetic tests, the sex of the child, and the surrogate mother’s conduct after birth.

State ballot measures and state legislatures have slowly but steadily legalized the use of marijuana. The specifics of the law have specific ramifications for people and businesses even if they never roll a joint.

As one example, Federal law still prohibits the use and sale and marketing of marijuana. Professionals advising employers, banks, and health care providers have unique issues in determining reactions to events. For example, should a bank do business with an organization marketing and selling marijuana? Can an accountant provide an appropriate audit? Can a lawyer help create a corporation for a weed based business?

Can a physician work for one? Most medical marijuana clinics fail to utilize doctor ownership, thus potentially violating the corporate practice of medicine doctrine in California.

The Week in Weed provides an on-going discussion of the ethical and legal issues of a weed business. In a recent report that independent investment is slow to embrace the business but:

All businesses need to be careful with hiring and paying attorneys. American Express at Open Forum reports on the different ways that law firms take advantage of clients. Some examples: Including charges for corporate, estate planning and real estate forms that they have used multiple times and billed to multiple clients. Being shuffled off to less experienced attorneys and paying for the “supervision” by the senior attorney; and, refusing to negotiate the billable hour and replacing it with things like flat fees or other creative billing.

According to AMEX: “All attorneys should be open to negotiating their hourly rate, especially if you have a big project or will pay a cash retainer up front,” said Street. “Better yet, ask them to quote you a flat rate for your project. Most attorneys are still learning how to think about flat- or project-rate billing, so they may need your help in setting the fee, but you will then have complete control over the cost of your representation.”

Avoiding Excessive Legal Fees

All businesses, especially healthcare businesses, avoid the problems of hiring lawyers by creating a continuing relationship with a lawyer. Businesses of a certain level have the ability to hire in-house counsel, an important position in any organization. The General Counsel of a firm can protect it from many legal threats and can help the organization find appropriate legal support.

Smaller businesses can’t afford to hire General Counsel. Given the more and more complicated legal framework, owners of businesses must find appropriate avenues to obtain advice to avoid the harsh penalties of a legal mistake.

Healthcare Law and the General Counsel

Healthcare firms must make sure that they get accurate and specialized lawyering to support their business. One step is to follow the guidelines of AMEX when hiring a lawyer and make sure they are getting the right advice and paying the appropriate amount for the advice. Negotiating and setting a set plan for the advice needed is the best alternative to the billable hour.

Kinley Law Practice works with businesses to create and implement safeguards to ensure that clients are in compliance with all applicable federal and state regulations. These safeguards not only minimize exposure to administrative fines, costly lawsuits and settlements, they also ensure maximum profits and efficiency.

KLP’s general counsel services are a unique way for healthcare clients to obtain the expertise and accessibility of an in-house legal team without having to endure the burden of employing and managing a team of attorneys. Our clients typically engage us on a set monthly retainer based on business size, volume of work involved and other business specific factors. We provide a complete turnkey solution for all legal needs, or we can work with existing in-house counsel to provide specialized guidance with a particular challenge, such as with post-acquisition employment compliance integration or the development and maintenance of a licensure platform.

As “outside general counsel” we provide the following services personalized to the specific needs of our clients:

Compliance and Risk Assessment. We personally visit our clients’ business site and conduct a top to bottom review of processes to assess risk and establish relationships with staff. We will know each key employee by name and each of those individuals has access to our expertise at their fingertips.

Contract Review and Negotiation. We draft, revise and update all form contracts and negotiate and document the multitude of contracts our clients need to function. We provide a complete solution from equipment purchase deals to commercial leases and everything in between.

Litigation Management. We manage all aspects of litigation by outside counsel or handle litigation needs ourselves. If hiring other outside counsel is in the best interest of our clients, we will work with outside counsel to keep track of budgets and strategies. We monitor important filings, deposition transcripts and coordinate trial and alternative dispute resolution tactics.

Onsite Office Visits and Management Meetings. We partner with our clients to on site at regular intervals to enable us to work face-to-face with key management personnel in identifying and implementing specific strategies for improving efficiency in a legally sound manner. We regularly participate in key management meetings and provide input as needed.

Transactions and Real Estate Needs. We advise our clients in all aspects of transactions such as the purchase of physician practice, to structuring the ownership of medical office buildings occupied by physician owners. We also negotiate space leases between hospitals and physicians as well as consult in the construction, financing and equipping of continuing care retirement communities, nursing homes, and assisted living facilities.

In California, the Confidentiality of Medical Information Act (“CMIA”) creates rights for patients in their own personal records. While most attention is given to federal law, especially HIPAA and HI-Tech, when trying to understand what to do medical records.

California has created a strong statutory scheme to protect patients’ rights. Codified at Civil Code section 56.10, the Act provides that “No provider of health care provider, service plan or contractor shall disclose medical information regarding a patient of the provider of healthcare or an enrollee or subscriber of a health care service plan without first obtain an authorization” from the patient. The statute then goes on to proscribe in detail the requirements for authorization.

Violation the CMIA will result in fines and a civil cause of action against the party who provided the private healthcare information.

CMIA does have several exceptions. Some the exceptions require the healthcare provider to disclose information, for example under court order or for police or coroner investigations. Other exceptions allow, but do not required, the physician to disclose medical records to other health care providers and healthcare insurance companies. Healthcare providers may also provide information that has been scrubbed of identifiable information to public health studies and other companies who will allow the medical profession to better understand healthcare service.

University of California, Riverside. HIPAA and the Hi-Tech regulations impose burdens on healthcare providers on how private health information can be utilized. Given the potential penalties for missteps, this is an important topic for the healthcare industry to grasp. Tickets are still available!

As a recent Office of Civl Rights Report recently pointed out, 2016 was a record year for enforcement: “OCR has been on a tear, settling 11 cases in 2016 with resolution agreements and corrective action plans. The agency also won a decision by an administrative law judge in an enforcement action contested by a home healthcare and medical equipment supplier (see OCR Slaps Home Health Provider with Penalty.”

Private Health Information must be maintained and utilized in ways that protect the information from exposure.

Matt Kinley is a health care attorney and founder of Kinley Law Practice in California. You can contact him at matt@kinleylawpractice.com.

AVOIDING THE PROHIBITION AGAINST NON-PHYSICIAN OWNERSHIP OF MEDICAL ORGANIZATIONS

A management services organization (“MSO”) is an entity which would contract with a physician or a medical corporation owned and operated by physicians. The MSO could be owned by non-physicians. The physician or medical corporation can pay the MSO for everything. Employees would work for the MSO; the MSO would pay for the lease. The MSO would pay for all significant expenses and receive a fee for its services.

The Corporate Practice Medicine Doctrine (CPOM) is strong in California. Under this doctrine, physicians must control clinical decisions. The concern is that if business entities owned by non-physicians are permitted to control the rendering of care, they will subordinate clinical care to commercial considerations and profits. The objective, therefore, is to prevent non-physicians and non-physician-owned business entities from influencing treatment decisions.

This presents a significant constraint to physician business ventures. Specifically, if physicians or other clinical personnel work for entities other than professional medical corporations, they may be exposed to disciplinary risks, as well as to forfeiture of revenues.. For non-physician business partners, violating the CPOM may also bring both civil and, in extreme cases, potential criminal liability for engaging in medical practice without a license.

MSO

In California, the solution for avoiding violations of the CPOM in business ventures in which physicians work with businesses owned by unlicensed persons is a contractual relationship between the physician entity and the unlicensed business entity, or a “management services organization (MSO).” This is a business vehicle that permits unlicensed persons to provide services to physicians and their professional medical corporations. In its simplest form, an MSO provides basic practice support services to physicians and professional medical corporations via a contractual relationship, commonly known as a management services agreement. These services frequently include activities such as billing and collection, administrative support in certain areas, and electronic data interchange (e.g. electronic billing). Some MSO’s provide a broader set of services: the MSO may purchase many of the assets in a medical practice, such as office space or equipment. MSO’s can employ office support staff, and assist with a wide range of non-clinical functions. MSO’s can also assist in functions such as marketing. Often, MSO’s can reduce costs by bringing economies of scale and professional management experience into physician practices, thereby improving operational efficiency and reducing overhead costs.

the MSO must be carefully considered and constructed. Review and application of relevant laws and regulations is a must.